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Follow-up of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia (NCT02896829)

It's an observational study based on 98 patients included in the STIM trial to extend the monitoring of patients and to have molecular and clinical data, with long follow up. Are there late relapses? What has become patients who relapsed during STIM trial and restarted TKI (inhibitor tyrosine kinase) treatment?
  • Behavioral: Interruption of the treatment by Imatinib
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    Inclusion Criteria:
    • The patients should have been included in the STIM1 Study CHUBX 2006/06 (NCT00478985)
    Exclusion Criteria:
    • The patients not included or discharged prematurely from the STIM1 Study can not participate to the study
    Chronic myeloid leukemia (CML) is an hematopoietic stem cell disorder in which a t (9;22) (q34;q11) reciprocal chromosomal translocation gives rise to Philadelphia chromosome (Ph) and generates the BCR-ABL1 fusion gene encoding a constitutively activated protein tyrosine kinases (PTK). Tyrosine kinase Inibitors (TKIs) such as imatinib, by blocking BCR-ABL1 kinase activity, selectively eradicate CML cells and induce durable responses and prolong survival.

    CML patients treated with TKI are monitored by BCR-ABL1 RT-qPCR (Reverse Transcription real-time quantitative Polymerase Chain Reaction) performed from peripheral blood samples.

    A first multicenter study entitled STIM trial demonstrated that imatinib could be safely discontinued in patients with complete molecular remission (CMR) for at least 2 years (undetectable BCR-ABL1 transcript by RT-qPCR).

    Around 40% of these patients remain in a prolonged treatment-free remission (TFR) after treatment cessation. All molecular relapsing patients were sensitive when imatinib was re-challenged.

    The purpose of this STIM-FU study is to follow all the patients included in the STIM trial in order to evaluate their molecular status, vital status and ongoing treatment in patient with a first molecular relapse.

    This long term follow up will allow us to predict if a constant long term control of the disease is possible and to better define the clinical and biological CML-related factors predictive for a molecular relapse after TKI discontinuation.

    19 locations

    France (19)
    • CHU d'Angers
      Not specified
      Angers, France, 49033
    • Institut Bergonié
      Not specified
      Bordeaux, France, 33076
    • CHU de Bordeaux - Haut-Lévêque
      Not specified
      Bordeaux, France, 33604
    • Hôpital Morvan
      Not specified
      Brest, France, 29285
    • Hôpital Henri-Mondor
      Not specified
      Creteil, France, 94000
    • Pôle de cancérologie
      Not specified
      Grenoble, France, 38043
    • Centre Hospitalier de La Roche Sur Yon
      Not specified
      La Roche Sur Yon, France, 85025
    • Centre Hospitalier de Versailles
      Not specified
      Le Chesnay, France, 78157
    • Hôpital Claude Huriez
      Not specified
      Lille, France, 59037
    • Hôpital Edouard Herriot
      Not specified
      Lyon, France, 69374
    • Institut Paoli Calmette
      Not specified
      Marseille, France, 13273
    • CHU Hôtel-Dieu
      Not specified
      Nantes, France, 44035
    • CHU de Nice
      Not specified
      Nice, France, 06202
    • Hôpital Saint Louis
      Not specified
      Paris, France, 75475
    • Hôpital Necker-Enfants Malades
      Not specified
      Paris, France, 75743
    • CHU de Poitiers
      Not specified
      Poitiers, France, 86021
    • Hôpital Civil
      Not specified
      Strasbourg, France, 67000
    • Hôpital Purpan
      Not specified
      Toulouse, France, 31059
    • CHU Brabois
      Not specified
      Vandoeuvre les Nancy, France, 54500
    Status:
    active not recruiting
    Type:
    Observational
    Phase:
    -
    Start:
    31 March, 2013
    Updated:
    03 October, 2017
    Participants:
    98
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